NCT07139639

Evidence-Based Evaluation of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease

Evidence-Based Evaluation and New Drug Development of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Zheng Liu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Taking the approach of promoting qi circulation and activating blood as the entry point, this study targets lower extremity arterial disease（LEAD） patients with TCM syndrome pattern of blood stasis due to qi stagnation. Using Guanxinning Tablets (a herbal formula with qi-moving and blood-activating properties) as the investigational medication, we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the classic herb pair (Chuanxiong Rhizoma-Salviae Miltiorrhizae) in preventing LEAD ulcer recurrence. This research aims to accumulate evidence-based medical data supporting new drug development.

Conditions

• Diabetic Lower Extremity Arterial Disease

Interventions

Type	Name	Description
DRUG	Guanxinning Tablets	Guanxinning Tablets * Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd. * NMPA Approval No. Z20150028 * Administration: 4 tablets orally, three times daily for 6 months
DRUG	Matching Placebo for Guanxinning	Matching Placebo for Guanxinning Tablets * Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd. * Drug Product Certificate of Analysis Approval No.YF-R-C037A-2024104-A * Administration: 4 tablets orally, three times daily for 6 months

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-11-01
• Completion: 2028-12-01
• First posted: 2025-08-24
• Last updated: 2025-08-24